Residual Lesion Score (RLS)
The aim of this research is to study whether a scoring system called the Residual Lesion Score will predict how children with congenital heart disease will do after cardiac surgery. We hope the scoring system will help doctors and nurses understand which parts of cardiac surgery may affect a child’s recovery after surgery. The score may help doctors and nurses take better care of infants at the time of cardiac surgery.The study began in the summer of 2015 and will be done at seventeen Pediatric Heart Network centers in the United States and Canada. About 1250 patients across the centers will be enrolled in this study.
Who can be in the study?
This study is enrolling children less than one year old who are undergoing one of the following cardiac surgeries: (1) repair of complete common atrioventricular canal; (2) repair of Tetralogy of Fallot with pulmonary stenosis; (3) repair of arterial switch operation; (4) stage I Norwood procedure for HLHS; or (5) repair of interrupted/hypoplastic arch or coarction with VSD closure.
What do we have to do to be in the study?
The study will be explained to you in detail by one of the study investigators. Once your questions have been answered, you will be asked to sign an informed consent form to enter the study. If you give permission for your child to participate in this study, we will record information about your child’s medical history, cardiac surgery and post-operative recovery, including your child’s echocardiograms (ultrasound examination of the heart) performed for his or her routine care around the time of surgery. We will also contact you one year after your child’s surgery to ask about any medical or surgical procedures that may have occurred since your child’s hospital discharge We will also ask you to sign a separate form (medical release) allowing us to obtain medical records from other hospitals or places that you go to for care. Your child’s participation in the study will not change his or her surgery or treatment.
How long will we be in the study?
Your child’s participation in the study will be for one year.
What are the possible benefits to being in this study?
Your child may not benefit directly from being in this study, but the information we learn from this study may help improve the care of other children who were born with a heart defect.
What are the possible risks to being in this study?
The risks of participating in this study include the potential risk for loss of confidential information about your child. Your child’s echocardiograms will be submitted to the Pediatric Heart Network Echocardiogram Core Laboratory located at Boston Children’s Hospital for review. Every effort will be made to remove identifying information from these studies before they are sent. If information potentially revealing your child’s identity cannot be removed from the echocardiogram prior to sending it to the core lab, the core lab will remove all identifying information before the echocardiogram is reviewed. The de-identified echocardiograms will be stored on secure servers for analysis. Study information will be stored in locked file cabinets on site and will only be accessible to project staff. All of the collected electronic data will be sent to the study central data center where there are many layers of electronic and physical security.
What are the costs to me to be in the study?
There will be no extra costs to you when you join this study. You must pay for all other costs related to your normal medical care such as hospital stays, surgery, drugs, lab tests, and doctor's fees which are thought to be standard medical care for patients with your condition.